BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, WEIGHTED LIGHT HANDLE, VISUM LED

    MDR report key: 2990981 · Received March 6, 2013

    Report

    Report Number
    0002031963-2013-00010
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT COULD NOT BE ABSOLUTELY CONFIRMED WHAT CAUSED THE REPORTED CHIPPING PAINT ON THE SURGICAL LIGHT HANDLES. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES REPORTED. THE USER FACILITY WAS SENT NEW LIGHT HANDLES AS REPLACEMENT COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE IN "(B)(4)", IT WAS OBSERVED THAT PAINT WAS CHIPPING ON THE SURGICAL LIGHT HANDLES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96161 PKG, WEIGHTED LIGHT HANDLE, VISUM LED VISUM LED SURGICAL LIGHT FSY STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1